Conventional pulsed-field ablation versus pulsed-field ablation with non-navigated three-dimensional mapping on the safety and efficacy for de novo pulmonary vein isolation during atrial fibrillation

Abstract Background Visualization of the multi-electrode pulsed-field ablation (PFA) catheter within a three-dimensional (3D) mapping system holds the potential to improve catheter maneuverability and enhance ablation outcomes, thereby improving procedural metrics and long-term outcome. Purpose The aim of our analysis, from a real-world nationwide registry, is to evaluate the impact of PFA with non-navigated 3D-mapping systems on safety and efficacy in the context of de novo pulmonary vein isolation (PVI) during atrial fibrillation (AF) ablation. Methods All consecutive patients undergoing de novo PVI-only AF ablation with the Farapulse system at 18 centers were included. A standard protocol-directed PVI was delivered using 2kV with 8 applications per vein. Additional lesions at PVs were performed at the operator’s discretion. Procedures were stratified according to the use or not of a non-integrated 3D-mapping system to validate the lesions (MAP vs Standard). Primary efficacy endpoint was freedom from any atrial arrhythmia recurrence during the follow-up period. Results Among 1184 patients, 321 (27.1%) were females, 1010 (85.3%) had paroxysmal AF (174 -14.7%- persistent AF), mean age was 62.0±10 years, mean LVEF was 58.4±7%. A 3D-mapping system was used to validate the lesion set in 223 (18.8%) of the cases. The number of patients with all PV isolated at first pass was 1129 (95.4%) with no difference between MAP and Standard procedures (STD: 95.7% vs MAP: 93.7%, p=0.215). The total number of PFA deliveries (38±8 vs 37±8, p=0.147) was similar between groups, while MAP procedures had longer skin-to-skin time (90[70-110] min vs 55[47-70] min, p<0.0001), Cath lab utilization time (120[105-150] min vs 70[60-90] min, p<0.0001), time to PVI (21[15-27] min vs 19[15-24] min, p=0.0002) or fluoroscopy time (21[16-27] min vs 15[11-21] min, p<0.0001). During a mean follow-up of 328[191-385] days, primary efficacy endpoint occurred in 689 out 809 (85.2%) patients with available outcome information. STD and MAP patients exhibited a similar arrhythmia recurrence rate (15.6% for STD cases, 10.9% for MAP cases, p=0.222). At cox regression analysis, no difference was found between STD and MAP patients (HR=0.8, 95%CI: 0.46 to 1.39, p=0.429), the time to recurrence was similar between groups (log-rank p=0.427). Two (0.2%) major complications occurred, all in the STD group. Conclusion In our real-life experience, the use of Farapulse PFA system for de novo PVI-only AF ablation was rapid, safe and effective leading to a high first-pass isolation rate and freedom from atrial arrhythmias during follow-up. A non-integrated 3D-mapping system was employed in a minority of cases and did not significantly affect acute or long-term success rates.